Robertville, Belgium
Gene Therapy for CD19-Positive Hematologic Malignancies (SENTRY-CD19)
VNX-101 is an investigational adeno-associated virus (AAV) gene therapy developed to express a secreted anti-CD19/anti-CD3 scFv diabody (termed GP101). GP101 binds both cluster of differentiation (CD)19 and CD3, inducing T-cells to kill both benign and malignant B-cells. Following a single intravenous (IV) infusion, the vector induces the liver and key tissues to continuously secrete GP101 into the bloodstream, resulting in long-term, consistent serum levels of GP101. Potential advantages of VNX-101 over autologous CAR-T therapy include it is off-the-shelf, provides a gentle onset of action, does not require lymphodepletion chemotherapy, engages all T-cells continuously (including those freshly produced from the bone marrow), and utilizes highly efficient signaling through the native T-cell receptor. In this 2-part study, dose-finding data from Part 1 of the study (n=~12 patients) will be used determine the dose for Part 2 in patients. Part 1 is a dose-finding PK study in adults ≥18 years old designed to determine the minimal dose that achieves target PK serum levels of GP101 at steady state (8-week timepoint) without dose-limited toxicities, defined as the recommended Part 2 dose (RP2D). Prior to VNX-101 dosing, subjects may undergo standard of care chemotherapy to meet dosing criteria. Part 2 (n=~20) will be opened following data safety monitoring board review of Part 1 data and is designed to determine the safety and pharmacokinetics (PK) of VNX-101 at the RP2D in a broader array of subjects. The age range for Part 2 will be expanded to include subjects ≥13 years old. Patients will be followed for safety and efficacy up to 5 years post VNX-101 dosing. Long-term follow-up assessments for safety will be conducted for 6 to 15 years post VNX-101 dosing.
Phase
1/2Span
331 weeksSponsor
Vironexis Biotherapeutics Inc.Valhalla, New York
Recruiting
Effect of Flavored, Carbonated Drinks on Salivary Flow, Salivary Composition, and Taste Perceptions
Previous studies have shown that drinking a beverage can stimulate the production of saliva and alter its composition. These effects could impact oral processing and taste perceptions. Various ingredients in beverages such as carbonation may affect saliva and oral processing. The objective of this study is to determine the effect of flavored carbonated beverages on salivary flow rate, saliva composition (pH, mucins, carbonic anhydrase, and total protein), and taste perceptions compared with unflavored and non-carbonated control drinks.
Phase
N/ASpan
14 weeksSponsor
PepsiCo Global R&DValhalla, New York
Recruiting
Healthy Volunteers
Effect of Adding Glycerol to Electrolyte Beverages on Fluid Balance in Healthy Euhydrated Men and Women at Rest
This is a two-part study. Subjects will be asked to complete either Part 1 or Part 2 of this study. Subjects can participate in both parts of the study if they are interested and available to complete all trials. However, they will be asked to complete Part 1 before enrolling in Part 2 of the study. Dosing days are separated by 2-15 days. Objective 1) To compare the effect of consumption of four no/low/moderate carbohydrate drinks with high electrolyte concentrations vs. placebo on fluid balance at rest. To enroll N=25 Objective 2) To compare the effect of consumption of two moderate carbohydrate drinks with low electrolyte concentrations vs. placebo on fluid balance at rest. To enroll N=70
Phase
N/ASpan
35 weeksSponsor
PepsiCo Global R&DValhalla, New York
Recruiting
Healthy Volunteers
A Research Study to Advance the CF Therapeutics Pipeline for People Without Modulators
People with Cystic Fibrosis (pwCF) who are genetically ineligible and/or not taking cystic fibrosis transmembrane conductance regulator (CFTR) modulators currently face future health that is considerably different from the approximately 90% of pwCF in the United States who benefit from CFTR modulators. New treatments are being advanced for pwCF who are genetically ineligible or not taking CFTR modulators and these therapies will include both nucleic acid-based therapies (NABTs) to address the underlying defect in CFTR and symptomatic therapies aimed at targeting the symptoms of CF. A key concern for this limited and underserved patient population is being able to advance multiple therapeutic programs in parallel. To complete these studies, CF researchers will need to be able to reach this community effectively while also promoting the use of innovative trial designs. The REACH Study is a prospective, longitudinal, observational research study to obtain research quality (i.e., monitored research) CF outcome data. Primary outcome endpoints of the Core study (collected across all study participants) are aligned with anticipated clinical trial outcome endpoints needed in overall development of therapies for the CF population unable to benefit from CFTR modulators. This study will also include sub-studies to obtain specialized measures which may help inform efficacy and safety evaluations of new therapies by providing CF control data. Finally, this study also seeks to assess research solicitation and research participation for the CF population that is modulator ineligible or not taking modulators. The observational data collected within this study may be used in characterizing this CF population, developing innovative trial designs, for comparison when evaluating new or experimental CF therapies, and/or in CF research.
Phase
N/ASpan
256 weeksSponsor
Nicole HamblettValhalla, New York
Recruiting
ARTEMIS - A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With a Heart Attack
Phase
3Span
115 weeksSponsor
Novo Nordisk A/SValhalla, New York
Recruiting
REvascularization CHoices Among Under-Represented Groups Evaluation: The RECHARGE Trial - Minorities
The RECHARGE: Minorities Trial is a multicenter, 1:1 randomized, open-label superiority trial. Patients meeting the eligibility criteria for whom there is equipoise for revascularization with CABG and PCI, as determined by the local Heart Team, will be included. Participants will be followed for 5-10 years. Telephone follow-up will be conducted by the a central follow-up coordinating center at 30 days, 3 months, 6 months, and thereafter every 6 months through 36 months post-randomization. After 36 months, follow-up will be performed every year (48, 60, 72, 84, 96, 108, 120 months). A repeat transthoracic echocardiogram and blood draw for serum creatinine, hemoglobin and lipids should be performed at 1 year, as per standard of care, at either an out-patient facility or in a hospital.
Phase
3Span
744 weeksSponsor
Weill Medical College of Cornell UniversityValhalla, New York
Recruiting
REvascularization CHoices Among Under-Represented Groups Evaluation: The RECHARGE Trial - Women
The RECHARGE: Women Trial is a multicenter, 1:1 randomized, open-label superiority trial. Patients meeting the eligibility criteria for whom there is equipoise for revascularization with CABG and PCI, as determined by the local Heart Team, will be included. Participants will be followed for 5-10 years. Telephone follow-up will be conducted by the a central follow-up coordinating center at 30 days, 3 months, 6 months, and thereafter every 6 months through 36 months post-randomization. After 36 months, follow-up will be performed every year (48, 60, 72, 84, 96, 108, 120 months). A repeat transthoracic echocardiogram and blood draw for serum creatinine, hemoglobin and lipids should be performed at 1 year, as per standard of care, at either an out-patient facility or in a hospital.
Phase
3Span
746 weeksSponsor
Weill Medical College of Cornell UniversityValhalla, New York
Recruiting
Chronic Subdural Hematoma Treatment With Embolization Versus Surgery Study
Phase
N/ASpan
205 weeksSponsor
The University of Texas Medical Branch, GalvestonValhalla, New York
Recruiting
Study of JK07 in Patients With Chronic Heart Failure
Phase
2Span
118 weeksSponsor
Salubris Biotherapeutics IncValhalla, New York
Recruiting
Transdermal Optical Imaging (TOI) as a Non-invasive Measure to Detect Changes in Hydration Status in Healthy Adults and Athletes
Phase
N/ASpan
48 weeksSponsor
PepsiCo Global R&DValhalla, New York
Recruiting
Healthy Volunteers